FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc.: Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (0.89mm), 260 cm (102").
- Recall number
- Z-1485-2014
- Recalling firm
- Merit Medical Systems, Inc.
- Product
- Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (0.89mm), 260 cm (102").
- Status
- Terminated
- Initiated
- 2014-04-14
- Posted
- 2014-04-22
- Terminated
- 2014-07-17
- Reason
- Discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035" 260 cm Guide Wire, catalog number LWSTFS35260EX, which has a straight tip and a stiff shaft. This lot was partially mixed with another lot of Laureate 0.035" 260 cm Guide Wire, catalog number LWSTDA35260EX, which has an angled tip, standard shaft and Chinese unit labeling.
- Root cause
- Process control
- Action
- Customers were notified on 4/14/14 via certified letter with instructions to identify product, discontinue use, and return products.
- Quantity
- 173
- Distribution
- Worldwide Distribution: USA Nationwide and China. No military/govt/VA consignees.
- Lot, serial or model codes
- Lot No. K556399, Expires 2016-10
- 510(k) numbers
- ["K120644"]
- PMA numbers
- not on file
- Product code
- DQX
- Firm FEI
- 1721504
- Firm city
- South Jordan
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28